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510(k) K800682

REAGENTS FOR DETERM. CHOLESTEROL/SERUM by Diagnostic Solutions, Inc. — Product Code CGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

Other clearances by Diagnostic Solutions, Inc.

  • K934892 — RELIEF PLUS ONE REAGENT STRIP MODIFICATION (January 11, 1994)
  • K924398 — UNI-CHECK REAGENT STRIP (December 23, 1992)
  • K921825 — QUICK-CHECK II REAGENT STRIP (August 18, 1992)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800689 — REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (May 30, 1980)
  • K800692 — REAGENT FOR DETERM. POTASSIUM/IN HUMAN (May 28, 1980)
  • K800687 — REAGENT FOR DETERM. GLUCOSE IN H/SERUM (May 28, 1980)
  • K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (May 28, 1980)
  • K800679 — REAGENTS FOR DETERM. ALKALINE PHOSPHATAS (May 28, 1980)
  • K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (May 28, 1980)

Other clearances for product code CGO

  • K850938 — CHOLESTEROL (June 25, 1985)
  • K811747 — KING DIAGNOSTICS CHOLESTEROL TEST (July 10, 1981)
  • K810090 — CHOLESTEROL REAGENT (January 26, 1981)
  • K781611 — CHOLESTEROL DET. IN SERUM (October 24, 1978)
  • K780545 — SR-PLUS DIRECT CHOLESTEROL TEST (May 26, 1978)
  • K772043 — ALPHA/CHOL (November 28, 1977)
  • K771833 — CHOLESTEROL (October 18, 1977)
  • K771313 — CHOLESTEROL REAGENT (August 3, 1977)
  • K771093 — UNIPAK CHOLESTEROL (July 21, 1977)
  • K770457 — CHOLESTEROL PROCEDURE, TEKPOINT TOTAL (May 3, 1977)